April 6, 2020
China NMPA and U.S FDA have been preparing regulatory establishments for the novel Coronavirus (Covid-19) since late January. Two regulatory authorities share the same progress: Emergency approval channels have been […]
April 2, 2020
The NMPA expert panel convening scientists, medical experts, government officials, manufacturer’s representatives and Clinical Research Organizations (CROs) from transcontinental locations is delivered online for the first time. The virtual conference […]
March 23, 2020
NMPA and National Health Commission jointly issued the Administrative Measures of Medical Device Expanded Access for Clinical Trial on March 20, implementing from the date of publication. The draft version […]
March 19, 2020
NMPA published the Review Points of CT Image-Assisted Triage and Evaluation Software for Coronavirus (COVID-19)-Infected Pneumonia on March 5, 2020. The document provides guidance to AI software manufacturers on the […]
March 10, 2020
NMPA published the Draft Document of “Transfer Certificate of Approved Imported Device to Domestic Enterprise for Manufacturing” on March 5, 2020 for feedback. Feedbacks need to be submitted by March […]